Kornimate/medical-research-clean huggingface dataset:
breast cancer pet/ct imaging with 68ga-pakti

Conditions: Breast Cancers; PIK3CA Mutation-Related Tumors; PI3K Pathway Activated Tumors; PET / CT

Summary: abnormal activation of the pi3k-akt signaling pathway in breast cancer patients is closely associated with tumor progression. phosphorylated akt (p-akt) serves as a key indicator of pathway activation. in this study, we utilize a novel probe, 68ga-pakti, which enables precise targeting of tumor p-akt expression levels to monitor pi3k-akt pathway activation. the aim of this study is to evaluate the diagnostic accuracy of 68ga-pakti pet/ct in detecting p-akt expression in breast cancer and to compare its performance with that of 18f-fdg pet/ct. a total of 20 patients with breast cancer will be enrolled. screening will be conducted within 14 days prior to administration of 68ga-pakti (from day -14 to day -1). subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68ga-pakti on day 0, followed by pet/ct imaging. biopsy/pathological results and conventional imaging findings will be followed up to validate the diagnostic efficacy of 68ga-pakti pet/ct in accurately detecting p-akt expression in breast cancer.


Eligibility criteria:
inclusion criteria: 1. voluntarily signs the informed consent form. 2. age ≥ 18 years. 3. pathologically confirmed or highly suspected breast cancer based on conventional imaging. 4. estimated life expectancy \> 3 months as determined by the physician. 5. agrees to practice strict contraception for at least 28 days following the pet/ct examination. 6. willing and able to comply with the study protocol. 7. has not undergone surgical resection of the lesion. 8. has participated in molecular testing at the precision oncology center of fudan university shanghai cancer center, and harbors a pik3ca mutation, pten mutation, or upregulation of the pi3k-akt-mtor pathway. exclusion criteria: 1. pregnant or breastfeeding women. 2. unable to lie still on the pet/ct scanner bed during the examination or intolerant to pet imaging. 3. participation in another interventional clinical trial within 1 month prior to screening. 4. patients who are lost to follow-up. 5. any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.
triplenex (triple fixed combination) use evaluation in patients with glaucoma

Conditions: Glaucoma; Quality of Life (QOL)

Summary: this project purpose is to evaluate the effectiveness, ocular surface quality, medication adherence and quality of life in 46 glaucoma patients in use of three separate drugs (bimatoprost 0.3%, timolol maleate 0.5% and brimonidine tartrate 0.2%) comparing with triple combination, triplenex. in this clinical trial approved by the unifesp etical and research comitte, volunteer glaucoma patients will be recruited from unifesp glaucoma sector and vermais glaucoma sector. they will be randomly divided em two groups,group i is going to be treated with triplenex (1 drop twice a day) and grupo ii with brimonidine tartarate (1 drop twice a day), timolol maleate (1 drop twice a day) and bimatoprost (1 drop at night). at baseline visit a complete ophthalmolgical exam will be performed along with three questionnaires ("ocular surface disease index", "glaucoma treatment compliance assessment tool" and "national eye institute visual function questionnaire"),retinography, visual field, optic nerve oct in all patients. this procedure will be repeated at baseline and within 4, 8, 12 weeks.

this clinical study aims to compare the use of the hypotensive eye drop triplenex, a fixed triple combination (currently available only in brazil, mexico, and chile), with the globally recognized combination of the same drugs administered separately. the combination of the eye drops bimatoprost 0.3%, timolol maleate 0.5%, and brimonidine tartrate 0.2% in separate vials is traditionally used in patients with difficult intraocular pressure control or advanced glaucoma that requires a low target pressure for proper disease management. the fixed triple combination intends to improve patient adherence while maintaining the efficacy of intraocular pressure control and progression of glaucoma. this study arises in the context of a lack of literature comparing triplenex to the three original drugs and the absence of data on its influence on adherence, ocular surface, and the quality of life in the daily lives of glaucoma patients.

Eligibility criteria:
inclusion criteria: * patients with diagnosed glaucoma * above 18 years old * in use of at least 3 different glaucoma eyedrops classes * informed consent form granted exclusion criteria: * secundary glaucoma * previous ocular surface disease * previous intraocular surgeries (except cataract) * previous ocular trauma * current use of contact lenses use * current use of steroids or systemic medications that may change ocular surface * any study's drug intolerance

Keywords: glaucoma triplenex triple combination qol addherence
the frequency and risk factors of delayed graft function

Conditions: Delayed Graft Function; Kidney Transplant; Complications

Summary: delayed graft function (dgf) is an important phenomenon after kidney transplantation with direct and indirect implication on graft survival. although its incidence and risk factors have been studied after cadaveric kidney transplantation cases, only few data is available regarding transplants from living donors. the present study was performed to investigate the frequency and risk factors of dgf among living-unrelated kidney transplant recipients among three transplant centers in part of middle east.

in this multi-center retrospective study, data from 480 transplanted patients had been collected from existing local hospital registries in three countries (iran, kingdom of saudi arabia (ksa), and kuwait) with 3 years post transplantation follow-up. data for this study was collected based on routine clinical practice of medical practitioners across the participating countries. a case report data collecting form was designed for gathering the data including the recipient and donor's characteristics prior to transplantation, and after transplantation up to three years post transplantation. using binary logistic regression analysis, the potential risk factors for occurrence of dgf in living donor transplantations were tested. graft and patient survival at 1, 2 and 3 years depending on follow-up time was evaluated.

Eligibility criteria:
inclusion criteria: living donor kidney recipients with complete prior transplantation data and 3 years post transplantation follow up, including those who died during the observation period exclusion criteria: kidney recipients younger than 18 years
mindset interventions to facilitate taking cold showers

Conditions: Psychological

Summary: the primary objective of this trial is to determine whether mindsets sustain the feasibility of taking cold showers over a 3-month period. secondary objectives are to determine potential effects on physical and mental well-being, sleep quality, skin and hair appearance, perceived illness, and related sickness absences from work.


Eligibility criteria:
inclusion criteria: the investigators will include * healthy participants between 18 and 65 years of age, * which do not take cold shower on a regular basis. * as there are no known gender differences, participants of both female and male sex are included. exclusion criteria: the investigators will exclude * pregnant or lactating women by self-report and * subjects with cardiac, pulmonary or any other severe disease by self-report.
acute effects of high- vs. low-frequency vibration foam rolling

Conditions: Myofascial Release

Summary: this study aims to compare the acute effects of low- and high-frequency vibration foam rolling on flexibility, dynamic balance, and vertical jump in young male recreational athletes. fourteen athletes will be included in this study, planned as a randomized controlled cross-over study. all athletes wil be completed three interventions: 1) low-frequency vibration foam rolling (lfvfr), 2) high-frequency vibration foam rolling (hfvfr), 3) rest control. pre- and post-test assessment will be included flexibilty, assessed with the sit-and-reach test; dynamic balance, assessed with the y balance test; and vertical jump, assessed with the vertical jump test.


Eligibility criteria:
inclusion criteria: * to volunteer to participate in the study * to engage in sports activities at least 2-3 days a week exclusion criteria: * players with a history of major sports injury or time-loss injury that required surgery * musculoskeletal problems that compromised their performance in the study * a history of lower extremity pathology in the 3 months before the study * used any drugs or supplements

Keywords: recreational athletes flexibility dynamic balance vertical jump
prelude-1 (prospective evaluation of radiotherapy-induced biologic effects in colorectal cancer oligometastatic patients with lung-limited disease: evolution of cancer genetics and regulatory immune cells)

Conditions: Colorectal Cancer Metastatic

Summary: prelude-1 study is a pilot intervention trial that aims to describe the immunologic and genetic evolutions induced by stereotactic body radiationtherapy (sbrt) treatment in oligometastatic colorectal cancer (omcrc) patients with two-three nodules lung-limited disease.

prelude-1 study is a monocentric pilot interventional trial. the study concerns all patients enrolled with a diagnosis of oligometastatic colorectal cancer (omcrc) with two-three nodules lung-limited disease and treated with sbrt technique. sbrt will be delivered according to a risk-adapted protocol. tumor genetic background will be assessed on primary ffpe (formalin fixed paraffin embedded) tissues. liquid biopsy will be done on blood samples collected before radiotherapy (rt) start and after 40 days to monitor tumor dna evolution. the most direct method to assess cancer genetics relies on sampling of tumor dna and its characterization through whole genome sequencing techniques (ngs, next generation sequencing). the study will last 48 months, divides as follow: 24 months of enrollment phase and up to 24 months of follow-up. follow-up will be performed on the 40th day after the end of radiation treatment and then every 3 months until progression.

Eligibility criteria:
inclusion criteria: * age \<80 years * cytological or histological diagnosis of colorectal adenocarcinoma * two or three asymptomatic lung nodules smaller than 25 mm * eastern cooperative oncology group (ecog) performance status 0 or 1 * available formalin fixed paraffin embedded (ffpe) of resected primary tumor * negative pregnancy test for all potentially childbearing women * patient candidates to sbrt exclusion criteria: * previous systemic anti-tumor treatments (allowed treatment with capecitabine or fluorouracil and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated at least 6 months before) * neutrophils \ 1.5 times the maximum normal value; got and/or gpt \>5 times the maximum normal value and/or bilirubin level \>3 times the maximum normal value * previous or concomitant malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix) * active or uncontrolled infections * other concomitant uncontrolled diseases or conditions contraindicating the study drugs at clinician evaluation * presence of brain metastases * refusal or inability to provide informed consent * impossibility to guarantee follow-up

Keywords: sbrt liquid biopsy metastatic disease cancer genetics ngs omcrc
effects of alkaline phosphatase on renal function in septic patients

Conditions: Severe; Septic; Shock

Summary: septic shock is the most common cause of death in patients requiring intensive care. the kidney is one of the first organs to fail, stressing the importance to search for clinical interventions that may protect the kidneys during sepsis. alkaline phosphatase functions as a host defence molecule and is present in many cells and organs (e.g. intestine, placenta, liver, kidney and bone). alkaline phosphatase has a dual mode of action. first, it binds to and, subsequently, dephosphorylates lipopolysaccharide (lps). second, the enzymatic reaction product monophosphoryl-lps is a non-toxic substance for mammals which acts as a partial antagonist on the lps receptor complex. in several animal studies, administration of alkaline phosphatase attenuates the inflammatory response and reduces mortality. it is unknown whether these results can be extrapolated to septic patients . we studied the effects of alkaline phosphatse administration on kidney damage and function in patients with severe sepsis or septic shock.


Eligibility criteria:
inclusion criteria: * written informed consent * proven or suspected gram-negative bacterial infection * two out of four systemic inflammatory response syndrome (sirs) criteria existing for less than 24 h * acute onset of end-organ dysfunction in the preceding 12 h exclusion criteria: * prior therapy with alkaline phosphatase * known allergy for cow milk * probable death within 24 h * chronic renal failure requiring hemodialysis or peritoneal dialysis * acute pancreatitis with no established source of infection * hiv seropositive * pregnant or lactating * confirmed gram-positive or fungal sepsis * treatment with immunosuppressants including high doses of glucocorticosteroids

Keywords: alkaline phosphatase sepsis kidney function
gut oxygenation and laparoscopy

Conditions: Laparoscopy; Laparotomy; Oxygenation,; Ischemia-Reperfusion Injury

Summary: patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and ischemia-reperfusion injury.


Eligibility criteria:
inclusion criteria: * proven cleft colon cancer, signed informed consent exclusion criteria: * emergency surgery, * cancer infiltrating adjacent organ (at ct scan), * severe cardiovascular (new york heart association class \> 3 ), * respiratory (arterial po2 \< 70 mmhg), * renal (plasma creatinine \> 3 mg/dl) or hepatic (child c) dysfunction

Keywords: laparoscopy, laparotomy, oxygenation, ischemia-reperfusion injury
orthodontic archwire effectiveness trial

Conditions: Malocclusion

Summary: this study protocol is for a randomised clinical trial which aims to test two materials used as orthodontic archwire to compare firewire archwires to copper nickel titanium (cniti) archwires. both professional and patient related outcome measures are to be used to fully evaluate performance.

this is a randomised clinical trial of firewire and cniti as orthodontic aligning archwires. a two group single blind parallel multicentre study design in a national health service primary care setting in england will be used. patients will be recruited from those attending the practices for orthodontic treatment that meet the inclusion and exclusion criteria. online randomisation will allocate to one of the two groups, stratified by centre and age group (adolescent / adult). sample size calculation indicates a total sample size of 42, but allowing for dropouts and missing data the investigators will recruit 64, 32 to each group. patients will be treated according to a strict clinical protocol including customised damon q fixed appliances and defined archwire sequence. participants will be seen at initial 5 week intervals for data collection after new archwire placement, and otherwise at routine 10 week intervals. primary outcome data (rate of alignment) will be collected over the initial 10 weeks and secondary outcomes over the duration of the treatment (18 months approx).

Eligibility criteria:
inclusion criteria: * 12 years of age or older * class 1 incisor relationship (british standards institute classification) * labial segment crowding in upper and / or lower arch \>4mm * little's irregularity index in upper and / or lower arch \>4mm * eligible for nhs orthodontic treatment * planned non-extraction upper and lower fixed appliance orthodontic treatment exclusion criteria: * previous fixed appliance orthodontic treatment * previous functional appliance treatment * planned use of fixed auxiliary appliances (e.g. quadhelix, trans palatal arch) * cleft lip and palate or other craniofacial anomalies * hypodontia (excluding third molars), or missing teeth due to previous extraction * abnormal root morphology on pre-treatment radiographs * confirmed history of nickel allergy * a medical history resulting in them taking analgesics for a chronic condition * limited mouth opening or other contra-indication to intra-oral scanning

Keywords: orthodontic wires
a study of the drug i131-omburtamab in people with desmoplastic small round cell tumors and other solid tumors in the peritoneum

Conditions: Desmoplastic Small Round Cell Tumor; Peritoneal Cancer; Peritoneal Carcinoma

Summary: the purpose of this study is to test any good and bad effects of the study drug 131i-omburtamab. 131i-omburtamab could prevent the cancer from returning, or delay the cancer from getting worse, but it could also cause side effects. researchers hope to learn more about how 131i-omburtamab works in the body, and how effective it is in treating cancer. 131i-omburtamab is not approved by the fda to treat dsrct or other cancers of the peritoneum.


Eligibility criteria:
inclusion criteria: * have the diagnosis of dsrct confirmed at mskcc * age \>1 year and able to cooperate with radiation safety restrictions during therapy period. * prior to intraperitoneal catheter placement * at least 1 weeks must have elapsed since prior chemotherapy * at least 2 weeks must have elapsed since biologic therapy * toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline at the completion of surgery, patients must fulfill all of the additional following criteria: * have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic or have had gtr of this disease at the time of catheter placement exclusion criteria: * prior progression of disease * prior hypothermic intraperitoneal chemotherapy (hipec) * cardiac, pulmonary, and neurologic toxicities are greater grade 1 per nci ctcae version 5 * renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per nci ctcae version 5) * history of allergy to mouse proteins * patients with grade 4 hypersensitivity reaction to radiolabeled iodine

Keywords: solid tumor peritoneal solid tumor dsrc i131-omburtamab memorial sloan kettering cancer center 19-182
the median effective dose (ed50) of paracetamol and morphine : a study of interaction study

Conditions: Postoperative Pain

Summary: the aim of our study is to define the median effective analgesic doses (ed50) of paracetamol, morphine, and their combination and determination the nature of their interaction administered iv for postoperative pain after moderate painful surgery using up-and-down and isobolographic methods.

ninety patients scheduled to undergo moderately painful surgery were included in one of three groups. determination of median effective (ed50) doses was performed by the dixon and mood up-and-down method. initial doses were 1.5g and 5mg, with dose adjustment intervals of 0.5g and 1 mg, in the paracetamol and morphine groups, respectively. the initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine. analgesic efficacy was defined as a decrease to less than 3 on a 0-10 numeric pain scale, 45 min after the beginning of drug administration. isobolographic analysis was used to define the nature of their interaction.

Eligibility criteria:
inclusion criteria: 1. asa physical status і or іі 2. moderately painful surgery patients 3. postoperative pain more than 3 on a numerical pain score (nps) - exclusion criteria: 1. contraindication to the use of paracetamol and morphine 2. pregnancy 3. age younger than 18 yr 4. patient weight less 65kg 5. intra-operative regional anesthesia, 6. intra-operative administration of analgesics other than fentanyl, 7. postoperative pain less than 3 on a numerical pain score (nps)

Keywords: paracetamol morphine median effective dose pain
phase iii trial bi 695502 plus chemotherapy vs. avastin® plus chemotherapy in patients with lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the objective of this phase iii trial is to establish statistical equivalence in terms of efficacy (best overall response rate \[orr\], proportion of patients with complete response \[cr\] plus partial response \[pr\]) until 18 weeks of first-line treatment with bi 695502 plus chemotherapy versus avastin® plus chemotherapy followed by maintenance monotherapy with either bi 695502 or avastin®.


Eligibility criteria:
inclusion criteria: adult patients aged \>=18 years with histologically or cytologically confirmed advanced nonsquamous non-small cell lung cancer (nsnsclc). mixed tumors should be categorized according to the predominant histology. note: nsclc should be predominantly nonsquamous. recurrent or metastatic disease (stage iv) with an indication for therapy with paclitaxel + carboplatin + avastin®. patients harboring tumors with unknown or without activating epidermal growth factor receptor (egfr) / anaplastic lymphoma receptor tyrosine kinase (alk) mutation maybe included provided chemotherapy is standard of care. at least one measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1 based on independent central review. eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. adequate hepatic, renal, and bone marrow function: life expectancy \> 6 months based on clinical judgment. further inclusion criteria apply. exclusion criteria: prior therapy with monoclonal antibodies or small molecule inhibitors against vascular endothelial growth factor (vegf) or vegf receptors, including avastin®. prior systemic therapy for metastatic disease. prior systemic anticancer therapy or radiotherapy for locally advanced nsnsclc if completed \<12 months prior to screening. previous malignancy other than nsclc in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix. symptomatic brain metastasis. diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung, nsclc not specified (ns) or nsclc not otherwise specified(nos). any unresolved toxicity \> common toxicity criteria grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy). history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. thrombotic or hemorrhagic event =\< 6 months prior to screening. further exclusion criteria apply.